Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT00366366
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2006-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2006-08-18', 'studyFirstSubmitQcDate': '2006-08-18', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose'}], 'secondaryOutcomes': [{'measure': 'Ab conc/titers against all vaccine antigens'}, {'measure': 'Safety: Solicited symptoms, unsolicited AEs and SAEs'}]}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'referencesModule': {'availIpds': [{'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '217744/075', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '17987229', 'type': 'BACKGROUND', 'citation': 'Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Ann Acad Med Singap. 2007 Oct;36(10):801-6.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Weeks', 'minimumAge': '11 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female infant at the age of 11 - 17 weeks.\n* Written informed consent obtained from the parents or guardians of the subject.\n* Free of obvious health problems as established by clinical examination before entering into the study.\n* Hepatitis B vaccine at birth and one month of age.\n\nExclusion Criteria:\n\n* Previous vaccination against measles, mumps, rubella and/or varicella.\n* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* A family history of congenital or hereditary immunodeficiency.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.\n* Major congenital defects.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.'}, 'identificationModule': {'nctId': 'NCT00366366', 'briefTitle': "To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age", 'orgStudyIdInfo': {'id': '217744/075'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Infanrix-Hexa', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}